Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma

Recruiting

• Conditions: Hepatocellular Carcinoma; Hepatectomy; Laparoscopic Hepatectomy

• Registration Number: NCT06950827
• Lead Sponsor: West China Hospital

Brief Summary

Although traditional open right hemihepatectomy is a mature technique, the incision is usually very large; Intraoperative bleeding may be excessive, and postoperative liver failure is also prone to occur. In recent years, compared with traditional open surgery, laparoscopic surgery has many advantages, such as smaller surgical incision and faster postoperative recovery. In recent years, more and more centers have gradually transitioned to performing right hemihepatectomy through laparoscopy as much as possible. However, due to the difficulty of the surgery, steep learning curve, and postoperative complications, its adoption is limited to high-capacity surgical centers. Despite significant progress in laparoscopic liver resection technology, its clinical efficacy remains controversial, especially in laparoscopic right hemihepatectomy. More research is needed to confirm the feasibility and safety of this surgery. At present, it is unclear whether there is a difference in textbook outcomes (TO) between HCC patients undergoing open and laparoscopic right hemihepatectomy, and the association between TO and patient survival prognosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-05
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-05-10
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age ≥ 18 years old;
2. The lesion is limited to the right half of the liver and diagnosed as hepatocellular carcinoma based on paraffin pathology and immunohistochemistry results;
3. The type of surgery is elective surgery;
4. The patient's preoperative liver function was Child Pugh A or B grade, and the preoperative ASA (American Society of Anesthesiologists) rating was I, II, or III.

Exclusion Criteria

1. Pathological confirmed cholangiocarcinoma, mixed cell carcinoma, or extrahepatic metastatic malignant tumors;
2. Previous history of upper abdominal surgery;
3. Simultaneously undergoing adjacent abdominal organ resection, major vessel and biliary reconstruction surgery, except for the gallbladder;
4. Merge adjacent organ invasions except for the gallbladder, with main blood vessels, bile duct cancer emboli, or distant metastases;
5. Lost to follow-up or loss of primary clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Textbook outcome	From January 2018 to January 2023	Textbook outcome (TO) was defined as the absence of intraoperative grade ≥ 2 incidents (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), postoperative liver failure grade B or C (according to the severity grading of the International Study Group of Liver Surgery), major postoperative complications within 90 days (Clavien-Dindo grade III or higher), readmission within 90 days after discharge due to surgery related major complications (Clavien-dindo Grade III or higher), in-hospital or 90-day mortality and the presence of R0 resection margin (i.e. 1mm or more tumor free margin).

Secondary Outcome Measures

Name	Time	Method
Overall survival	From January 2018 to January 2023	Overall survival (OS) was defined as the interval from liver resection to death or the last follow-up.
Disease-free survival	From January 2018 to January 2023	Disease-free survival (DFS) was defined as the time from liver resection to disease recurrence or death from any cause.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China